KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method

Contraception Clinical Trial

— KYSS  

Official title:

KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182140
• Other study ID #: 19186
• Status: Completed
• Start date: July 6, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used contraceptive methods and reasons for use of Kyleena.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1134
• Est. completion date: March 31, 2020
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women requesting contraception with Kyleena. The woman's informed decision for contraception with Kyleena was made before and independently from the study as per investigator's routine practice

• Written informed consent.

Exclusion Criteria:

• Contraindications for Kyleena according to the local market authorization/SmPC

• Mental incapacity to consent and provide data during the observational study

• Women participating in an investigational program with interventions outside of routine clinical practice.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Kyleena
Kyleena - intrauterine delivery system containing 19.5 mg LNG

Locations

Country	Name	City	State
Belgium	Many locations	Multiple Locations
Canada	Many locations	Multiple Locations
Germany	Many locations	Multiple Locations
Mexico	Many locations	Multiple Locations
Norway	Many locations	Multiple Locations
Spain	Many locations	Multiple Locations
Sweden	Many locations	Multiple Locations
United States	Radiant Research	Akron	Ohio
United States	Physician's Research	Draper	Utah
United States	New England Center for Clinical Research Primacare Research, LLC	Fall River	Massachusetts
United States	TMC Life Research	Houston	Texas
United States	Jennifer Grube, MD, FACOG	Lakewood	Colorado
United States	Lawrence OB/GYN Clinical Research, LLC	Lawrenceville	New Jersey
United States	Eastern Carolina Women's Center	New Bern	North Carolina
United States	Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic	Pleasant Grove	Utah
United States	ProHEALTH Care Associates	Port Jefferson	New York
United States	Saginaw Valley Medical Research Group, LLC	Saginaw	Michigan
United States	Physician Care Clinical Research LLC	Sarasota	Florida
United States	Visions Clinical Research	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Mexico,  Norway,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall satisfaction with Kyleena assessed by questionnaire	The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).	approximately at 12 months after insertion or at premature discontinuation
Secondary	Overall satisfaction with Kyleena assessed by questionnaire	The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).	approximately 4-12 weeks after insertion
Secondary	Ease of insertion assessed by investigator	The rating is based on the categories easy, slightly difficult, very difficult.	Day 1
Secondary	Pain at insertion assessed by participant	The rating is based on the categories none, mild, moderate, or severe	Day 1
Secondary	Satisfaction with the menstrual bleeding profile with Kyleena assessed by questionnaire	Satisfaction with the menstrual bleeding profile with Kyleena assessed by women who did and did not experience menstrual bleeding during the last three months when answering the question "How satisfied were you with your menstrual bleeding pattern?" respectively.; The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).	after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion

External Links

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